Clinical Trial: Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Prospective, Randomized, Open-label, Controlled Trial of Cyclooxygenase-2 Inhibitor (Celecoxib; Celebrex®) for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer.

Brief Summary: In extrahepatic bile duct cancer and pancreatic cancer, we will treat postoperatively with COX2 inhibitor and assess survival rate and recurrent rate.

Detailed Summary:

Patients : total 220 patients

  • Extrahepatic bile duct cancer : 55 patients for administration of COX2 55 patients for control group
  • Pancreas cancer : 55 patients for administration of COX2 55 patients for control group

Indication

  • After operation of extrahepatic bile duct cancer or pancreas cancer
  • Age : 19 - 70 years old
  • The patients who agree to consent sheet.

Contraindication

  • Impossible of administration due to severe postoperative morbidities (bleeding, bowel obstruction, pancreatic fistula, biliary fistula)
  • Preexisting heart disease: Ischemic heart disease, Heart failure. Severe uncontrolled hypertension (systolic BP>160)
  • Renal insufficiency: CCR < 50 or serum creatinin >3.0
  • Hepatic insufficiency: Liver cirrhosis or active hepatitis
  • Preexisting allergic reaction history for NSAIDs or Sulfonamide
  • Current drug intake: Warfarin. Lithium, Fluconazole, Aspirin, Celecoxib
  • Preexisting Asthma. Especially aspirin-sensitive asthma.
  • Contraindications to aspirin, clopidogrel or celecoxib
  • The patients who refuse trial
  • The patients who has Psychogenic problem

Allocation

    Recurrent rate and survival rate


Original Primary Outcome:

  • Safety [ Time Frame: 2 years ]
    Number of participants with adverse events Kinds of adverse events
  • Short term outcome [ Time Frame: 2 years ]
    Recurrent rate and survival rate


Current Secondary Outcome: Long term outcome [ Time Frame: 4 years ]

Recurrent rate and survival rate


Original Secondary Outcome: Long term outcome (survival rate, recurrence rate) [ Time Frame: 4 years ]

Information By: Seoul National University Hospital

Dates:
Date Received: March 31, 2009
Date Started: November 2008
Date Completion: June 2017
Last Updated: October 27, 2016
Last Verified: October 2016